510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061844Substantially Equivalent

Dynasty Acetabular Shell and Cocr Acetabular Liner

Wrightmedicaltechnologyinc, Arlington TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061844 is the FDA 510(k) clearance record for DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER, a class III device, cleared for Wrightmedicaltechnologyinc on under FDA product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)). FDA records list 302 510(k) clearances for Wrightmedicaltechnologyinc, from to . As of , FDA records show no recalls naming K061844.

Clearance record

Decision date
Received
(160 days to decision)
Product code
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Regulation
21 CFR 888.3320
Device class
Class III
Review panel
Orthopedic
Applicant
Wrightmedicaltechnologyinc 5677 Airline Rd., Arlington TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDL

Trailing 12 months

FDA records hold no clearances under product code JDL in the trailing twelve months.

FDA records show no clearances under product code JDL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260